臨床および実験皮膚科学研究ジャーナル
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概要

Efficacy and Tolerability of a Tretinoin 0.02%, Clindamycin 0.8% and Glycolic Acid 4% Gel in Acne: A Multicenter, Prospective, Pragmatic, Assessor-Blinded, 12-Week Trial on 159 Subjects

Massimo Milani*, Chiara Cortelazzi, Paolo Chieco, Anna Ferrazzi, Nicola Gargano, Elisa Maiani, Amanda Mazzi, Maria Grazia Mannino, Daniela Marciani, Sergio Pastena, Silvia Pugliarello, Valentina Salamone, Teresa Sisto, Roberta Scarselli, Carmen Solaroli, Gustavo Spano

Background: Topical retinoid and antibacterial agents are commonly used as first-line treatments in mild/moderate acne vulgaris (AV). Adherence to retinoid treatment could be limited by the low local tolerability. Literature data show that up to 15% of patients prematurely stop the treatment with retinoids because of skin irritation. A medical device in gel formulation containing tretinoin (0.02%), glycolic acid (4%) and clindamycin (0.8%) is available. So far, no real-life, prospective data regarding efficacy and tolerability of this gel are available. We performed a prospective, multicenter, pragmatic 12-week, assessor-blinded trial. Primary outcomes were the changes of Total acne lesions (TL) count. Secondary outcomes were the evolution of Global Acne Grading System score (GAGS) e and Noninflammatory (NI-L) and Inflammatory (I-L) lesions count. An additional secondary outcome was also to evaluate the local tolerability of the gel. Materials and methods: In a real-life multicenter trial, 159 subjects with mild/moderate AV of the face were enrolled after their informed consent in a 12-week trial. Subjects were instructed to apply the gel once daily at evening. Baseline GAGS score was calculated, and a baseline picture of the face was also taken. Visits were performed after 6 and 12 weeks. Clinical evaluation and pictures were performed at the same time-points. GAGS score, NI-L and I-L calculation were performed evaluating subjects’ pictures coded in a randomized fashion by an assessor unaware of time-sequence. At week 6 and 12, an Investigator Global Assessment (IGA) score, using a 5-point scale was also calculated. Outcomes evaluation was performed on an Intention-to-treat basis. Results: A total of 134 (84%) subjects concluded the 12-week treatment period. Twenty-five subjects (16%) concluded prematurely the trial due to poor local tolerability. At baseline the total number of TL was 17 ± 10. Active treatment reduced significantly TL to 11 ± 7 after 6 weeks and to 6.3 ± 5 after 12 weeks, representing a -63% reduction in comparison with baseline. The mean ± SD GAGS score at baseline was 17.3 ± 8. GAGS score was reduced significantly to 11.8 ± 4 after 6 weeks and to 6.3 ± 3 at the end of treatment (a -63% reduction). Both NI-L and I-L lesions numbers were significant reduced at week 6 (NI-L: -42%; I-L:-35%) and at week 12 (NI-L:-65%; I-L:-65%). Tolerability was evaluated good/very good in 123 out of 134 subjects (91%). Conclusion: This gel containing tretinoin, glycolic and clindamycin, used as monotherapy in the treatment of mild to moderate acne, has shown to be effective in reducing TL, NI-L, I-L and GAGS score. The local tolerability profile is in line with other topical retinoids products.